Regulatory Services Manager - NCCT (Remote)

American Addiction Centers • Charlotte, NC

1d • Remote

About The Position

Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence is seeking a full-time Regulatory Services Manager. This role provides administrative direction and coordination for policies, procedures, and programs across all clinical sites, ensuring compliance with protocols, contracts, and regulatory requirements such as HIPAA, FDA, HHS, NIH, and OSHA. The manager will oversee a large clinical research staff, monitor clinical functions, develop computerized methods for reporting research activities, and assist with protocol development and study operations. This position also involves establishing working relationships with other departments and organizations, ensuring compliance with Medical School and University requirements, and preparing operational reports.

Requirements

• Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or, an equivalent combination of education and experience.
• Experience in medical/research environment preferred.
• Excellent verbal and written communication skills
• Demonstrates knowledge of scientific and statistical principles
• Ability to travel to affiliate sites, clinical sites and national meetings
• Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices

Responsibilities

• Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites.
• Provides guidance and advice in the completion of initial and annual IRB approvals.
• Monitors the completion and approval of all IRB requests.
• Ensures that all aspects of all studies are conducted in accordance to the applicable protocol and contract.
• Ensures that all HIPAA regulations, compliance and regulatory requirements are met.
• Acquires timely information regarding HIPAA privacy and security guidelines.
• Analyzes and determines the effect on the clinic activities and implement changes to maintain compliance with HIPAA and all other regulations, such as FDA, HHS, NIH, and OSHA.
• Participate in audits of cooperative groups and affiliates.
• Manages a large clinical research staff including hiring, performance evaluations, merit recommendations, promotions, transfers, and schedules.
• Monitors clinical functions and participant flow management.
• Develops procedures to ensure participant satisfaction and to maintain consistency throughout all clinics.
• Directs the development of computerized methods for monitoring and reporting on research activities as well as the analysis of data.
• Assists principal investigators and project managers in developing progress reports and quality control monitoring.
• Assists in protocol development activities, study operations, and closing of studies.
• Provides guidance to principal investigators in transitioning staff as funding begins/ends.
• Establishes working relations with other departments and organizations and assists in integration of studies when appropriate.
• Facilitates and develops relationships with NIH, FDA, etc.
• Provides guidance and oversight in determining how personnel, space, and equipment may be utilized across studies to improve efficiency.
• Plans and coordinates construction, renovation and maintenance activities within or related to the clinic.
• Ensures that all requirements of the Medical School and the University comply to the conduct of the clinical research.
• Ensures that all technical requirements of the funding agency are met, including auditing requirements.
• Coordinates and prepares operational reports and analyses setting forth progress, adverse trends and appropriate recommendations.
• Participates and supports internal and external meetings and committees.
• Assists in implementing institutional and departmental policies.
• Manages special projects and other initiatives as assigned.
• Performs other related duties incidental to work described herein.

Benefits

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1-10 employees